Clinical Study Schedule of Activities
1.0.0 - trial-use

Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions

## Resource Profile: ResearchStudySoa - Mappings

Active as of 2023-04-18

Mappings for the ResearchStudySoa resource profile.

### Mappings for BRIDG 5.1 Mapping (https://bridgmodel.nci.nih.gov)

ResearchStudySoa
ResearchStudy | ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
identifier | No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
title | No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol | StudyProtocolDocumentVersionPublicTitle.name
partOf | CompanionStudyRelationship
status | StudyOverallStatus.code
primaryPurposeType | StudyProtocolVersion.primaryPurposeTypeCode
phase | StudyProtocolVersion.phaseCode
category | InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
focus | InterventionalStudyProtocol.interventionTypeCode
condition | StudyCondition.code
contact | PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact | StudyProtocolDocument, StudyProtocolDocumentVersion
keyword | DocumentVersion.keywordCode; DocumentVersion.keywordText
location | StudyProtocolVersion.participatingLocationCode
description | StudyProtocolDocumentVersion.publicDescription
enrollment | InterventionalStudyProtocol.interventionGroupQuantity
period | ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
sponsor | RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
principalInvestigator | StudyInvestigator
site | PlannedStudySite; StudySite
reasonStopped | StudyOverallStatus.studyStoppedReasonCode
note | No BRIDG mapping
arm | Arm
name | Arm.name
type | Arm.typeCode
description | Arm.description
objective | StudyObjective
name | No BRIDG mapping (BRIDG has a description, but not a name)
type | StudyObjective.typeCode

### Mappings for HL7 v2 Mapping (http://hl7.org/v2)

ResearchStudySoa
ResearchStudy | OBX

### Mappings for RIM Mapping (http://hl7.org/v3)

ResearchStudySoa
ResearchStudy | Entity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
text | Act.text?
contained | N/A
extension | N/A
modifierExtension | N/A
identifier | .identifier
protocol | .outboundRelationship[typeCode=DEFN].target
partOf | .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status | .status
enrollment | .participation[typeCode=SBJ].role
period | .effectiveTime
sponsor | .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
note | .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
arm |
id | n/a
extension | n/a
modifierExtension | N/A
objective |
id | n/a
extension | n/a
modifierExtension | N/A

### Mappings for ClinicalTrials.gov Mapping (http://clinicaltrials.gov)

ResearchStudySoa
ResearchStudy |
identifier | Organization's Unique Protocol ID; Secondary IDs
title | Brief Title
protocol | Interventions; Arm/Intervention Cross-Reference
phase | Study Phase
category | Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
focus | Focus of Study
condition | Conditions
contact | Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
relatedArtifact | Citations, Links, Available Study Data/Documents
keyword | Keywords
description | Detailed Description
enrollment | Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
period | Study Start Date (start); Study Completion Date (end)
sponsor | Sponsor
principalInvestigator | Principal Investigator
site | Facility
reasonStopped | Why Study Stopped
arm | Arms
name | Arm Label
type | Arm Type
description | Arm Description

### Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

ResearchStudySoa
ResearchStudy |
identifier | FiveWs.identifier
status | FiveWs.status
focus | FiveWs.what[x]
condition | FiveWs.what[x]
enrollment | FiveWs.subject[x], FiveWs.subject
period | FiveWs.done[x]
sponsor | FiveWs.actor
principalInvestigator | FiveWs.actor
site | FiveWs.where[x]
reasonStopped | FiveWs.why[x]